Phase 2 Trial of G207 + 5 Gy Radiation for Children With High-Grade Gliomas
M.D. Anderson Cancer Center
Summary
The goal of this clinical research study is to learn about the safety and effects of G207 combined with radiation therapy in patients with recurrent or progressive high-grade glioma (HGG).
Description
Primary Objective: To assess the efficacy of G207 administered intratumorally followed by 5 Gy radiation within 24hours in patients with recurrent or progressive high-grade glioma (HGG) as measured by postprogression overall survival (pp-OS), focused on patients with one progression following their priorsurgery and radiotherapy, compared to matched historical controls. Secondary Objectives: To describe the pp-OS survival in patients treated with G207 + 5 Gy with more than one progression following their prior surgery and radiotherapy To establish safety and characterize toxicity of G207 +…
Eligibility
- Age range
- 3–21 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: Exclusion Criteria: Pregnancy Pregnant women are excluded from this study. Female patients of childbearing potential must have a negative serum or urine pregnancy test. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. Pregnant women are excluded from this study because G207 is an agent with the potential for teratogenic or abortifacient effects. Lactation Status Lactating females are not eligible unless they have agreed not to breastfeed their infants Because there is an unknown potential risk for adverse even…
Interventions
- DrugG207
Given by injection
Location
- UT MD AndersonHouston, Texas